Studies: Akebia completed two carcinogenicity
studies, a two-year study in rats and a six-month study in mice, results of which showed no carcinogenic effect of vadadustat.
Exposure to pyrrolizidine alkaloids in food, in particular for frequent and high consumers of tea and herbal infusions, is a possible long-term concern for human health due to their potential carcinogenicity
, say EFSAs experts.
The first bioassays for identifying chemicals posing a greater and immediate danger for carcinogenicity
to individuals were first developed about 100 years ago (Yamagiwa and Ichikawa 1918).
In addition, the advisory committee's input was requested on developing a strategy to implement human-based predictive approaches for complex toxicological endpoints such as developmental toxicity and carcinogenicity
of drinking coffee, mate, and very hot beverages.
The popular herbicide had faced an uncertain future amid conflicting advice on its possible carcinogenicity
Together, these efforts will help in designing better testing strategies to assess carcinogenicity
without the need to use animals while at the same time safeguarding against human exposure to harmful chemicals.
The clinical holds placed on the ARIKACE programmes in NTM and CF were based on an initial review by FDA of the results reported by Insmed of a long-term rat inhalation carcinogenicity
study of ARIKACE.
In a new study, the authors demonstrate for the first time that hepatocyte-like cells, derived from pluripotent stem cells, have a high potential to reveal chemical carcinogenicity
in in vitro hazard assessment assays.
Biopharmaceutical company Insmed Incorporated (NasdaqCMINSM) said on Monday that its phase 3 clinical trials for ARIKACE is in clinical hold based on an initial review of the interim results of a long-term rat inhalation carcinogenicity
The monograph identified 20 "high-priority" carcinogens for which the evidence of carcinogenicity
is substantial but not yet conclusive for humans.
All available data suggest that there is no indication for phototoxicity, acute toxicity, systemic toxicity (after repeated application), developmental toxicity, genotoxicity or carcinogenicity